In an effort to solve some of these issues, or at least make progress, in August, CMS went live with Blue Button 2.0, an API that gives developers access to four years of Medicare Part A, B, and D data for 53 million beneficiaries. Patient data includes the type of Medicare coverage, drug prescriptions, primary care treatment, and cost.

Although it's not as detailed as a medical device manufacturer would like, it's worth experimenting with. Access to prescription history and other healthcare information could potentially drive decision support, provide tighter integration with other devices and systems, and/or enhance patient care.

"If a medical device has a contraindication for a disease or medication, Blue Button 2.0 could provide a first pass screening for the contraindication," said Andrew Boyd, MD, associate professor of biomedical and health information sciences in University of Illinois at Chicago's College of Applied Health Sciences.

For example, say a diabetic patient visited a nutritionist that's not affiliated with his doctor's health system. If his blood glucose monitor "knew," using Blue Button 2.0 data, that he saw that nutritionist and modified his diet, it could incorporate this information into blood sugar history reports. His primary care doctor would then have a more detailed insight into why the patient's blood sugar levels changed over time.

Medical device companies thinking "beyond the device" to enhance products with connectivity and patient engagement features could aggregate Blue Button 2.0 data to provide patients with more customized information. The knee replacement that comes with its own app could prepopulate profiles with medical and prescription information.

Other potential uses include post-market surveillance and pre-market research. "The value depends on the device and the data needed," says Boyd. "There are 80,000 ICD-10 [disease] codes, plus procedure codes, and between 30 and 40,000 FDA-approved drugs in Medicare Part D in the API."

Elements also included in Blue Button 2.0 profiles include gender, date of birth, race and claim details. CMS mapped more than 1,300 fields from the CMS claims data warehouse into the HL7 FHIR standard (Fast Healthcare Interoperability Resources) specification, a standard for exchanging healthcare information electronically.

Blue Button at Work

Some SaMD companies have already taken advantage of Blue Button 2.0 data. Humetrix launched iBlueButton, the mobile embodiment of the initiative, earlier this year. The app allows users to pull, receive, aggregate, store and share payer claims, provider EMR, and Blue Button 2.0 data. The app serves Medicare beneficiaries, veterans, and individuals using Tricare, the health program for the military.

EHR companies Epic, Allscripts, and Cerner have agreed to work with third-party apps so patients can access their health records on their phones. A few of these apps include Medisafe, a medication management app; RxREVU, a prescription intelligence platform; and CareEvolution, which provides interoperability, population health, and analytics technologies.

Removing Interoperability Barriers

CMS launched Blue Button 2.0 to add value for beneficiaries, providers, healthcare organizations, researchers and others in the healthcare and life science spaces. CMS.gov says research organizations can prepopulate medication lists for clinical trials patients. Doctors can access information on patient care provided outside of his or her health system for a more comprehensive patient view.

More than 700 developers have signed up to experiment with Blue Button 2.0. Tech heavyweights Amazon, Google, IBM, Microsoft, Oracle, and Salesforce signed a pledgeshowing their support and committing "to removing barriers for the adoption of technologies for healthcare interoperability, particularly those that are enabled through the cloud and AI."

What we have right now, Verma said, in a speech at the Interoperability Forum in Washington DC, in August 2018, is data in silos, systems that speak different languages and patients and providers that don't have the information they need to take charge of their health.

"One of the challenges Medicare recipients have comes from seeing multiple doctors," says Boyd. "Sometimes it's confusing to tell who is treating what disease. If a software is able to help visualize this information, and help patients and doctors understand who is treating what, and who is billing what, it would go a long way in helping reduce Medicare fraud and improving patient engagement."

Verma points out in her speech the oddity that patients don't yet have this level of access. "If my phone knows what podcast I might want to listen to next based on my purchase history, shouldn't our medical decisions be fully informed by our medical history?"

Blue Button 2.0 data isn’t the ideal solution for enhancing medical device features or interoperability, but Boyd sees it as a step in the right direction. "Blue Button billing data is one step removed from clinical decisionmaking, which would provide a more complete picture," he says. "However, the data from this model can be used for future, more detailed sharing. As devices become more sophisticated they're going to need a bigger clinical integration for the device to perform at the optimal level."